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Multicenter Unsustained Tachycardia Trial (MUSTT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000480
First Posted: October 28, 1999
Last Update Posted: January 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To determine the value of electrophysiologic (EP)-guided antiarrhythmic therapy in coronary heart disease patients at increased risk for sudden death. The study included a controlled clinical trial and a registry.

Condition Intervention Phase
Arrhythmia Cardiovascular Diseases Coronary Disease Death, Sudden, Cardiac Heart Diseases Myocardial Ischemia Tachycardia, Ventricular Procedure: electrophysiology Drug: anti-arrhythmia agents Device: defibrillators, implantable Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1991
Study Completion Date: September 1996
Detailed Description:

BACKGROUND:

Cardiac arrest (sudden cardiac death) occurs relatively frequently in asymptomatic patients who have had myocardial infarctions, have ejection fractions less than 40 percent, and non-sustained ventricular tachycardia. However, it is not possible to predict who will die suddenly or when cardiac arrest will occur. Current efforts to reduce sudden death in such long-term survivors of myocardial infarction or in patients with coronary disease have produced results that are not very encouraging.

Such patients may feel quite well. They survived their myocardial infarction and may have slight or even moderate reduction of exercise ability, but by 'pacing' themselves, such patients can lead relatively normal lives. They may be aware of their arrhythmia because of short periods of palpitations which may only trouble them transiently. Consequently, this group of patients, many still in the prime of their lives, are at relatively high risk of dying suddenly.

The multicenter trial may reveal the most effective treatment for such patients, the value of electrophysiologic studies in predicting who is most at risk of sudden cardiac death, and whether electrophysiologic studies can help select the best mode of treatment. The protocol for performing programmed stimulation and serial drug testing is designed to mirror those currently in use by many practicing electrophysiologists.

DESIGN NARRATIVE:

Randomized, non-blind. Patients were assigned to standard therapy or to an aggressive arm consisting of electrophysiologic-guided antiarrhythmic therapy. Patients in the aggressive arm whose ventricular tachycardia was suppressible or who were still inducible, but who were hemodynamically stable in ventricular tachycardia, were followed on drug therapy. Otherwise, patients in the aggressive arm received an implantable defibrillator. The primary endpoint was sudden cardiac death or cardiac arrest. Patients without inducible sustained ventricular tachycardia were followed in a registry. Recruitment ceased on October 31, 1996 after a recommendation from the DSMB.

The study completion date listed in this record was obtained from the "End Date" entered in the NIH Query View Report (QVR).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women patients with documented coronary artery disease, ejection fraction less than or equal to 40 percent, and nonsustained asymptomatic ventricular tachycardia.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000480


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Kerry Lee Duke University
  More Information

Publications:
Buxton A, Lee K, Fisher J, Josphson M, Prystowsky E, DiCarlo L, Echit D, Greer S, Paker D, Talajic , Pryor D, Hafley G, for the Multicenter UnSustained Tachycardia Trial Investigators . Characteristics of spontaneous nonsustained ventricular tachycardia in patients with coronary disease do not predict inducible sustained ventricular tachycardia. Pacing Clin Electrophysiol 1995;18:349.

ClinicalTrials.gov Identifier: NCT00000480     History of Changes
Other Study ID Numbers: 70
U01HL045700-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: January 16, 2017
Last Verified: August 2004

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Ischemia
Coronary Disease
Coronary Artery Disease
Tachycardia
Myocardial Ischemia
Death, Sudden
Death, Sudden, Cardiac
Tachycardia, Ventricular
Pathologic Processes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Arrhythmias, Cardiac
Death
Heart Arrest
Anti-Arrhythmia Agents